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Fecal Microbiome Transplantation From Healthy Donors to Individuals With Fibromyalgia

NCT06424041 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-21

No results posted yet for this study

Summary

This study aims to investigate if a fecal microbiome transplantation (FMT) from healthy donors can reduce symptoms of fibromyalgia, a condition causing chronic pain that is difficult to treat and diagnose. Changes in the gut bacteria of women with fibromyalgia were previously reported, which might be linked to their symptoms. In mice studies, transferring gut bacteria from individuals with fibromyalgia was shown to increase sensitivity to pain, while treatment with antibiotics and transferring bacteria from healthy individuals reversed this effect. In a small open label trial in women, improvements in pain, fatigue, and sleep problems were observed after FMT. The investigators aim to perform a larger trial following a similar path. The study aims to conduct a double-blinded, randomized, placebo-controlled trial involving 80 women diagnosed with severe fibromyalgia. Half of the participants (40) will receive the active treatment, while the other half (40) will receive a sham treatment. The allocation to either group will be randomized. Throughout the study period, both the caregivers and the participants will remain unaware of their assigned groups until the study conclusion. Participants' symptoms will be documented and their blood and stool will be tested for changes in certain metabolites. If this treatment works, it could be a significant breakthrough in managing fibromyalgia and might provide new insights into its causes.

Conditions

  • Fibromyalgia

Interventions

OTHER

Fecal Microbiome Transplantation

Healthy donor fecal microbiome transplantation, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing

OTHER

Sham Fecal Microbiome Transplantation

Capsules containing preservative solution only, following depletion of the endogenous microbial communities using antibiotics and bowel cleansing

Sponsors & Collaborators

  • Rambam Health Care Campus

    lead OTHER

Principal Investigators

  • Amir Minerbi, MD-PhD · Rambam Health Care Campus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2026-03-31
Completion
2027-03-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06424041 on ClinicalTrials.gov